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NCT04171622
Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer
Phase 2 trial testing Lenvatinib in Metastatic Thyroid Gland Carcinoma in 25 participants. Participants enrolled and being followed up; not accepting new ones.
31 August 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 4 November 2021 |
| Primary completion | 31 August 2027 |
| Estimated completion | 31 August 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lenvatinib (LENVATINIB) — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Metastatic Thyroid Gland Carcinoma — all drugs for Metastatic Thyroid Gland Carcinoma →
- Poorly Differentiated Thyroid Gland Carcinoma — all drugs for Poorly Differentiated Thyroid Gland Carcinoma →
- Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 — all drugs for Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 →
- Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 — all drugs for Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Metastatic Thyroid Gland Carcinoma or Poorly Differentiated Thyroid Gland Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well lenvatinib and pembrolizumab work in treating patients with anaplastic thyroid cancer that is stage IVB and has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable), or stage IVC that has spread to other places in the body (metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Given lenvatinib and pembrolizumab may work better than giving either one alone in treating stage IVB or C anaplastic thyroid cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Evaluation of Overall Survival in Patients With Anaplastic Thyroid Carcinoma, 2000-2019.
Maniakas A, Dadu R, Busaidy NL, Wang JR, et al · · 2020 · cited 266× · PMID 32761153 · DOI 10.1001/jamaoncol.2020.3362 -
Surgery After BRAF-Directed Therapy Is Associated with Improved Survival in BRAF<sup>V600E</sup> Mutant Anaplastic Thyroid Cancer: A Single-Center Retrospective Cohort Study.
Zhao X, Wang JR, Dadu R, Busaidy NL, et al · · 2023 · cited 79× · PMID 36762947 · DOI 10.1089/thy.2022.0504 -
Recent advances in the management of anaplastic thyroid cancer.
De Leo S, Trevisan M, Fugazzola L. · · 2020 · cited 67× · PMID 33292371 · DOI 10.1186/s13044-020-00091-w -
Impact of Somatic Mutations on Survival Outcomes in Patients With Anaplastic Thyroid Carcinoma.
Wang JR, Montierth M, Xu L, Goswami M, et al · · 2022 · cited 53× · PMID 35977347 · DOI 10.1200/po.21.00504 -
Thyroid Cancers: From Surgery to Current and Future Systemic Therapies through Their Molecular Identities.
Lorusso L, Cappagli V, Valerio L, Giani C, et al · · 2021 · cited 51× · PMID 33803747 · DOI 10.3390/ijms22063117 -
Anti-Programmed Death Ligand 1 Plus Targeted Therapy in Anaplastic Thyroid Carcinoma: A Nonrandomized Clinical Trial.
Cabanillas ME, Dadu R, Ferrarotto R, Gule-Monroe M, et al · · 2024 · cited 42× · PMID 39446377 · DOI 10.1001/jamaoncol.2024.4729 -
Novel Inhibitor-Based Therapies for Thyroid Cancer-An Update.
Ratajczak M, Gaweł D, Godlewska M. · · 2021 · cited 37× · PMID 34769260 · DOI 10.3390/ijms222111829 -
What is the status of immunotherapy in thyroid neoplasms?
Garcia-Alvarez A, Hernando J, Carmona-Alonso A, Capdevila J. · · 2022 · cited 30× · PMID 35992118 · DOI 10.3389/fendo.2022.929091
Verify or expand the search:
- PubMed search for NCT04171622
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Metastatic Thyroid Gland Carcinoma
Currently open trials in the same condition.
- NCT04693377 — Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME T · NA · recruiting
- NCT04061980 — Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V · Phase 2 · active not recruiting
- NCT03181100 — Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer · Phase 2 · active not recruiting
- NCT02152995 — Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer · Phase 2 · active not recruiting
- NCT01947023 — Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery · Phase 1 · active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04171622 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04171622.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing